Pfizer and BioNTech initiated a Pfizer funded, 30,000 patient, Phase II/III trial for vaccine candidate BNT162b2 (one of four in development) on July 27. BNT162b2 will be administered as two 30 mcg immunizations. The vaccine elicited neutralizing antibodies in older adults (65-85 years of age) greater than the level seen in a panel of 38 recovered COVID-19 patients.
Moderna and NIAID initiated an NIAID funded, 30,000 patient, Phase III trial (NCT04470427) for COVID-19 vaccine candidate mRNA-1273 on July 27. The vaccine will be administered as two 100 mcg immunizations given 28 days apart.
AstraZeneca is evaluating its COVID-19 vaccine, AZD1222, in a 2,000 patient, Phase I/II trial in South Africa (NCT04444674) and in a 10,260 Phase II/III trial in the U.K (NCT04400838).
Johnson & Johnson initiated a 1,000 patient, Phase I/IIa trial (NCT04436276) on July 22 in the U.S. and Belgium with initial results expected in September.
COVID-19 Vaccine Pricing: Pfizer plans to price the two dose COVID-19 vaccine regimen at a minimum of $19.50 per dose or $39 for the two dose course of immunizations for the additional 500 million doses the U.S. can purchase under an Agreement. The price will be the same for other developed countries that make the same volume commitment. AstraZeneca and Johnson & Johnson have agreed to sell their vaccines near cost and may be charging as low as $3 per dose. Moderna may price the two dose COVID-19 vaccine regimen at $50 to $60. However, given the pricing from other companies, they will likely charge a lower price.
Roche announced that in the BARDA sponsored 28-day, 450 patient, Phase III COVACTA trial (NCT04320615), treatment with tocilizumab did not improve clinical status ventilator-free days or mortality compared to placebo in hospitalized patients with severe COVID-19-associated pneumonia. Patients treated with tocilizumab were discharged sooner than those in the placebo group (20 vs 28 days).
NIAID is comparing lenzilumab plus remdesivir to remdesivir monotherapy on the need for mechanical ventilation in hospitalized patients with COVID-19, in the 28-day, 200 patient, BIG EFFECT trial (NCT04351152).
New Dedicated COVID-19 Antibody Page
Check out the status of COVID-19 monoclonal antibodies under development from AstraZeneza, Lilly, Regeneron and Vir on our new Blood-Derived Products Under Evaluation or the Treatment of COVID-19 web page.